Hemicraniectomy After Middle cerebral artery infarction with Life-threatening Edema Trial
| ISRCTN | ISRCTN94237756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94237756 |
| Protocol serial number | 2002B138 |
| Sponsor | Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) |
| Funder | Netherlands Heart Foundation (Nederlandse Hartstichting) (Netherlands) (ref: 2002B138) |
- Submission date
- 16/06/2005
- Registration date
- 24/08/2005
- Last edited
- 06/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Hendrik Bernardus van der Worp
Scientific
Scientific
P.O. Box 85500
HP G.03.228
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 2509111 |
|---|---|
| h.b.vanderworp@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | HAMLET |
| Study objectives | In patients with space-occupying hemispheric infarction, decompressive surgery not only reduces mortality substantially, but also improves functional outcome in survivors, as compared with conservative treatment. |
| Ethics approval(s) | Approved by the medical ethical committees of all participating centres. |
| Health condition(s) or problem(s) studied | Ischaemic stroke; space-occupying hemispheric infarction |
| Intervention | Patients will be randomised to either surgical or conservative treatment. Randomisation will be stratified for the intended mode of conservative treatment (intensive care versus stroke unit care; see below). The choice of conservative treatment is left at the discretion of the local investigator, but will usually depend on the standard mode of treatment in the participating centre. Decompressive surgery will consist of a large hemicraniectomy and a duraplasty. |
| Intervention type | Other |
| Primary outcome measure(s) |
Score on the modified Rankin Scale (mRS) at one year |
| Key secondary outcome measure(s) |
The scores on the NIH Stroke Scale (NIHSS), the Barthel Index (BI), and the Montgomery and Asberg Depression Rating Scale (MADRS) and quality of life as measured with the SF36 and a visual analogue scale (VAS) at one year. In addition, the mRS, NIHSS, and BI will also be determined at 3 and 6 months, and the mRS, BI, MADRS, and SF36 also at 3 years after randomisation. |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 112 |
| Key inclusion criteria | Patients may be enrolled in the study if all of the following criteria are met: 1. Diagnosis of acute ischaemic stroke in the territory of the middle cerebral artery, with an onset within 96 hours prior to the planned start of the trial treatment 2. Score on the National Institutes of Health Stroke Scale (NIHSS) greater than or equal to 16 for right-sided lesions or greater than or equal to 21 for left-sided lesions 3. Gradual decrease in consciousness to a score of 13 or lower on the Glasgow Coma Scale (GCS) for right-sided lesions, or an eye and motor score of 9 or lower for left-sided lesions 4. Ischaemic changes on computed tomography (CT) involving two thirds or more of the territory of the middle cerebral artery (MCA), and space-occupying oedema formation. Displacement of midline structures on CT is not a requirement for inclusion. 5. Age 18 up to and including 60 years 6. Possibility to start trial treatment within 3 hours after randomisation 7. Written informed consent by a representative of the patient |
| Key exclusion criteria | Patients will be excluded from the study for any of the following reasons: 1. Ischaemic stroke of the entire cerebral hemisphere (anterior, middle, and posterior cerebral artery territories) 2. Decrease in consciousness (partially) explained by a cause other than oedema formation, such as metabolic disturbances or medication 3. Two fixed dilated pupils 4. Treatment with a thrombolytic agent in the 12 hours preceding randomisation 5. Known systemic bleeding disorder 6. Pre-stroke score on the modified Rankin Scale greater than 1 or less than 95 on the Barthel Index 7. Life expectancy less than 3 years 8. Other serious illness that may confound treatment assessment |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 85500
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2013 | Yes | No | |
| Results article | results | 01/09/2013 | Yes | No | |
| Results article | results | 01/10/2013 | Yes | No | |
| Protocol article | protocol | 11/09/2006 | Yes | No |
